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ABSTRACT
Surgical face masks are an important component of surgical apparel. The masks are expected to
perform as barriers and provide increased protection to the patients and health care workers. In
this study, the Bacterial Filtration Efficiency (BFE) of six commercially available surgical face
masks was determined for two microorganisms. Fabric characteristics (weight, thickness, pore
size, and resistance to synthetic blood strike through) thought to influence the barrier
effectiveness were measured and the relationship between these characteristics and BFE was
examined. Two challenge microorganisms, Staphylococcus aureus and Escherichia coli were
evaluated in this study. For five of the six masks evaluated, the BFE against the challenge
microorganism S. aureus was higher than when the challenge microorganism was E. coli. The
mask with the lowest mean pore size and lowest maximum pore size had the highest BFE for both
microorganisms evaluated, indicating that a relationship exists between pore size and BFE.
Although the effectiveness of the face mask In 1999 Davis reviewed the test methods
for reducing surgical site infections has been used for the evaluation of face masks
controversial, a number of major effectiveness [18]. Bacterial Filtration
organizations have published guidelines for Efficiency (BFE), both in vivo and in vitro,
health care workers to minimize risks of is a widely accepted method of evaluating
exposure which include face masks. They face masks. In these tests, the bacteria
include the Centers for Disease Control penetrating the face masks are collected,
[CDC], Association of Operating Room cultured and counted to determine the
Nurses [AORN], Occupational Safety and number of Colony Forming Units (CFU’S)
Health Administration [OSHA] and the that penetrate the mask. The in vitro test
Operating Room Nurses Association of uses positive and negative controls to
Canada [ORNAC]. AORN recommends determine the initial number of bacteria.
that “all persons entering restricted areas of The challenge bacteria are contained in a
the surgical suite should wear mask when mist, which is produced by aerosolizing the
open sterile items and equipment are bacteria with 0.1% peptone water in a
present” and that masks be worn along with nebulizer. The masks are placed directly
Article Designation: Refereed 2 JTATM
Volume 3, Issue 2,Fall 2003
over the opening of an Anderson sampler. measured and evaluated. Although the fit
The aerosol consists largely of droplets that of the mask and leaks between the face and
simulate expulsion from the wearer. The the mask interface are known to be
current BFE tests are used with the important performance considerations, they
microorganism S. aureus. However there have not been addressed in this study.
are a number of microorganisms in addition
to S. aureus that are known to cause Materials and Methods:
nosocomial infections and other serious
health problems. Nosocomial infections, In this study, two components of the FDA
which are defined as those infections recommended areas were evaluated, 1)
originating in the hospital or healthcare liquid resistance and 2) filtration efficiency.
center, occur in about 5% of all patients Six commercial face masks, each from a
admitted to the hospital, with 41% being different manufacturer, were selected for
urinary tract infections, 18% surgical, and evaluation (Table 1). Three of the face
16% respiratory.[19] Postoperative wound masks (#1-3) were three ply with a pleated
infections occur in up to seven percent of construction, and three (#4-6) were molded
surgical patients and require patients to face masks.
remain in the hospital an average of 7.3
extra days at an additional average cost of Properties that characterize the fabric, such
$3,152.[20, 21] Although a variety of as thickness, weight, and pore size, were
pathogens are encountered in the hospital measured in addition to the liquid resistance
environment, a relatively limited number and bacterial filtration efficiency. These
cause the majority of hospital infections characteristics were determined in
including Escherichia coli, Pseudomonas accordance with standard testing procedures
aeruginosa, Enterococcus faecalis, Candida (Table 2). Liquid barrier properties were
albicans, and Staphylococcus aureus.[20] measured according to ASTM F-1862-98:
Standard Test Method for Resistance of
Microorganisms have varying characteristics Medical Face Masks to Penetration by
that can influence their potential ability to Synthetic Blood. This test method is
penetrate the facemask material including designed to evaluate penetration of the
shape, size, and their surface characteristics. masks by synthetic blood under high
A wide variety of studies have evaluated the velocity. In this project varying degrees of
BFE of face masks, however there have velocity were examined to determine the
been a limited number of microorganisms influence of pressure on the level and
evaluated in these studies.[4,22,23] mechanism of transmission. Velocity spray
Willeke, et. al reported that rod-shaped pressures of 80 mmHg, 120 mmHg, and 160
bacteria penetrate less than spherically mmHg were selected.
shaped bacteria of similar size.[22] In
addition, few studies have evaluated the The Bacterial Filtration Efficiency for each
BFE of the face masks with specifically mask was determined in accordance with
engineered fabric characteristics ASTM Test Method F2101-01, Evaluating
the Bacterial Filtration Efficiency (BFE) of
In this study, the BFE of six commercially Medical Face Mask Materials, Using a
available surgical face masks was Biological Aerosol of Staphylococcus
determined for two microorganisms, S. aureus. Two bacteria were selected for
aureus and E. coli. Fabric characteristics evaluation in this study, S. aureus and E.
that influence the barrier effectiveness were coli.
1 Tie-on Surgical Face Mask 3-ply, pleated rayon outer web with polypropylene inner
web
3 Sofloop Extra Protection Mask 3-ply, pleated blended cellulosic fibers with polypropylene
and polyester, ethylene methyl acrylate strip
4 Aseptex Fluid Resistant Molded rayon and polypropylene blend with acrylic binder
5 Surgine II Cone Mask Molded polypropylene and polyester with cellulose fibers
S. aureus is a gram positive cocci that is The percent BFE was determined as
irregular in shape and often in grape like described in the test method for S. aureus,
clusters. Various diseases and ailments and modified for E. coli. The S. aureus was
including impetigo, toxic shock syndrome, obtained from American Type Culture
food poisoning and pneumonia are attributed Collection #6538 and E. coli was obtained
to S. aureus. An average coccus is about 0.5 from UGA Microbiology Department.
- 1.0 µm in diameter. E. coli is a gram Tryptic Soy Agar was the media used and
negative, rod shaped bacteria and averages Peptone water (Difco Dehydrated 500
1.1 to 1.5 µm in width by 2.0 to 6.0 µm in grams-Lot #1361000) was used as the
length. E. coli is a leading cause of urinary diluting agent as needed for the test method.
tract infections. Positive and negative controls were
Article Designation: Refereed 4 JTATM
Volume 3, Issue 2,Fall 2003
completed for each replication as directed in for Mask #6. The molded masks (#4, 5 & 6)
the test method. Using the positive control, were significantly higher in weight than the
it was determined that a challenge delivery pleated masks (#1, 2 & 3).
rate of 2200 +/- 500 viable particles per test
was required. This was achieved by diluting The percent Bacterial Filtration Efficiency
the bacterial stock solution to the for each mask and bacteria are presented in
appropriate bacterial concentration. The rate Table 4. For 5 of the 6 masks (not Mask
was determined by the results of the positive #4), the BFE values were higher when tested
control plates when the aerosol is collected with E. coli than for S. aureus. This was
in the six-stage viable particle cascade expected as the size and shape of the
impactor, with no test specimen clamped microorganisms differ and E. coli is larger
into the test system. The exposed plates and rod shaped when compared with S.
were placed in an incubator at 37oC for 24 aureus. S. aureus ranges in size from 0.5 to
hours. The CFU’s for each plate were 1.0 microns and is round in shape. E. coli is
counted using the Protocol Bacteria Colony rod shaped and averages 1.1 to 1.5 µm in
Counter, Synopitcs Corporation, V 2.05. width by 2.0 to 6.0 µm in length.
The filtration efficiency percentages were
calculated using the equation provided in the Mask #3 had the highest %BFE for S.
test method: aureus and the second highest %BFE for E.
coli and the lowest mean pore size of the
100 (C-T) / C = %BFE face masks examined here. This indicates a
relationship between pore size and BFE and
where C = average plate count total for test further testing should be completed to
controls and T = plate count total for test investigate this relationship.
sample.
Mask #3, also had the lowest maximum pore
Results and Discussion size of 27.19 µm. This is a critical
parameter to measure as this indicates the
The fabric characterization results for the largest pore detected in the sample and
three face masks are presented in Table 3. therefore particles may be transmitted
The pleated masks had lower pore size through this opening, hence reducing the
means than the molded masks. Mask #3 had BFE. When considering the mean pore size
the lowest mean pore size, 16.9µm, followed and the maximum pore size for face Masks
by Mask #2 with a mean pore size of #1 and #2, their order from highest to lowest
19.29µm, and Mask #1 had the highest pore is reversed for these two parameters.
size of the pleated masks at 23.97 µm. The Although Mask #2 had a lower mean pore
mean pore size of the molded masks were size than Mask #1, the maximum pore size
significantly higher ranging from 31.72 µm was greater than that of Mask #1. This may
(Mask #6) to 51.0 µm (Mask #5). Although help explain why the BFE for the masks is
thickness was not significantly different for not in the same order as the mean pore size.
the masks, the basis weight ranged from Mask #2 had a slightly lower BFE for E. coli
58.567 gm/m2 (Mask #2) to 164.405 gm/m2 (98.53%) and S. aureus (88.18%) than did
Table 4. Face Mask Bacterial Filtration Efficiency - Mean and (Standard Deviation)